intermittent eating on glucose homeostasis in prediabetes

Conditions: PreDiabetes; Obesity

Summary: prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (tre). tre requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. the 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. this randomized controlled trial aimed to evaluate the effect of tre and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.

prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (tre). tre requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. the 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. preliminary evidence suggests that both tre and the 5:2 diet have beneficial effects on glucose control in type 2 diabetes. no much is known about the effects and molecular mechanisms by tre or the 5:2 diet improves glucose homeostasis in prediabetes. this randomized controlled trial aimed to evaluate the effect of tre and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care. all eligible participants will participate in an 8-week run-in phase in which they are fed the low-calorie-diet. participants who pass the run-in phase will be randomly assigned 1:1:1 to one of the three study groups (tre, the 5:2 diet and control groups). participants in the tre group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. participants in the control group were instructed to receive usual health care.

Eligibility criteria:
inclusion criteria: 1. men or women aged 18-75 years; 2. prediabetes; 3. body mass index (bmi)of 28.0 to 45.0 kg/m2; exclusion criteria: 1. history of hiv, hepatitis b or c (self-report) or active pulmonary tuberculosis; 2. diagnosis of type 1 and type 2 diabetes; 3. history of malignant tumors; 4. serious liver dysfunction or chronic kidney disease (ast or alt \> 3 times the upper limit of normal, or egfr\<30 ml/min/1.73 m2); 5. history of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; 6. history of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months; 7. history of cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; 8. being a smoker or having been a smoker in the 3 months prior to their screening visit; 9. taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; 10. currently participating in weight loss programs; 11. women who are pregnant or plan to become pregnant; 12. patients who cannot be followed for 24 months (due to a health situation or migration); 13. patients who are unwilling or unable to give informed consent.

Keywords: tre the 5:2 diet glucose homeostasis prediabetes obesity